FDA Device recall Z-2953-2026
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of One-Piece Guedel Airway, size 000, ISO 3.5, Light Green by Intersurgical, citing devices could potentially be occluded or partially occluded.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2953-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-15 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Intersurgical |
| Distribution | US |
Product
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Reason
Devices could potentially be occluded or partially occluded.
Identifiers
| code_info | REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Intersurgical
- One-Piece Guedel Airway, size 00, ISO 5.0, Blue
FDA Device · Class II · 2026-08-26 · Intersurgical - One-piece Guedel airway, size 3, ISO 9.0, yellow
FDA Device · Class II · 2025-08-13 · Intersurgical - One-piece Guedel airway, size 2, ISO 8.0, green
FDA Device · Class II · 2025-08-13 · Intersurgical - i-view video laryngoscope
FDA Device · Class I · 2025-07-23 · Intersurgical - Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
FDA Device · Class II · 2022-10-26 · Intersurgical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2953-2026%22
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